| Methods | Double‐blind, randomised, parallel‐group trial with 2:1 IFNb‐1a to placebo ratio | |
| Participants | 19 people with GBS fulfilling Asbury 1990 criteria within 14 days from the onset of symptoms and having Hughes 1978 disability grade > 2 | |
| Interventions | IFNb‐1a (Rebif) by subcutaneous injection 3 times a week starting with 22 μg per injection for the first week and continuing with 44 μg for subsequent weeks until a total of 24 weeks (n = 13) or placebo (n = 6). Participants stopped treatment upon reaching grade 2 | |
| Outcomes | Improvement in disability grade 4 weeks after randomisation, improvement by 1 or more disability grades 4 weeks after randomisation, time from randomisation to recovery of unaided walking Serious adverse events (defined as "fatal, life threatening, requiring or prolonging hospitalization, severely or permanently disabling, a new malignancy, or a known or suspected overdose") |
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| Funding source | Serono International provided financial support and supplied the drug and placebo | |
| Declarations of interest | The trial authors declared receipt of honoraria or travel grants and departmental research grants from Serono International | |
| Notes | Participants in both groups received IVIg. This was a safety and tolerability study. There was no unexpected interaction with IVIg. A significant effect on efficacy outcomes was not expected because of the small sample size | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Each centre was given study drug in a computer‐generated (information from the authors) random sequence by the trial statistician balanced to achieve a 2:1 ratio of IFNb‐1a to placebo |
| Allocation concealment (selection bias) | Low risk | Each centre was given study drug in random sequence balanced to achieve a 2:1 ratio of IFNb‐1a to placebo and concealed until all outcome measures, including attribution of causality of adverse events, had been collected |
| Blinding (performance bias and detection bias) All outcomes | High risk | No attempt was made to mask skin lesions from assessors |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Complete case analysis reported |
| Selective reporting (reporting bias) | Low risk | Complete case analysis of all outcomes reported |
| Other bias | Low risk | None detected |